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EC number: 288-752-8 | CAS number: 85895-78-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1975-11-12 to 1975-02-19
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
- Reference Type:
- review article or handbook
- Title:
- Potassium chloride - SIDS Initial Assessment Report for 13th SIAM
- Author:
- OECD SIDS
- Year:
- 2 001
- Bibliographic source:
- OECD SIDS. Potassium chloride, UNEP Publication: SIDS Initial Assessment Report 13th SIAM. Bern, 6-9 November 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Potassium chloride
- EC Number:
- 231-211-8
- EC Name:
- Potassium chloride
- Cas Number:
- 7447-40-7
- Molecular formula:
- ClK
- IUPAC Name:
- potassium chloride
Constituent 1
- Specific details on test material used for the study:
- - Appearance/state: Fine white crystalline material
- Batch No.: FDA 73-78
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: adult female and young adult males
- Weight at study initiation: 215 - 230 g
- Housing: Anmals were individually housed in mesh bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum, fresh tap water
ENVIRONMENTAL CONDITIONS
- Temperature: controlled, 72 - 98 °F
- Humidity (%): 40-74
Administration / exposure
- Route of administration:
- oral: gavage
- Details on mating procedure:
- - Impregnation procedure: cohoused, males were not allowed to impregnate more than one female per group.
- Proof of pregnancy: Observation of vaginal plug referred to as day 0 of gestation - Duration of treatment / exposure:
- Females were dosed beginning on day 6 and continuing through day 15 of gestation.
- Frequency of treatment:
- daily
- Duration of test:
- Until gestation day 20
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control
- Dose / conc.:
- 3.1 mg/kg bw/day
- Dose / conc.:
- 14.4 mg/kg bw/day
- Dose / conc.:
- 66.8 mg/kg bw/day
- Dose / conc.:
- 310 mg/kg bw/day
- No. of animals per sex per dose:
- 21-28 female animals were mated per dose group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Beginning on day 6 and continuing daily through day 15 of gestation, the females were dosed with 0, 3.1,14.4, 66.8 and 310 mg/kg bw/day potasium chloride by oral intubations. The controls were sham treated with the vehicle. On gestation day 20, all dams were subjected to Caesarean section under surgical anesthesia.
Examinations
- Maternal examinations:
- Body weights were recorded on days 0, 6, 11, 15 and 20 of gestation. All animals were observed daily for appearance and behavior with particular attention to food consumption and weight.
- Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes, examinations included: number of corpora lutea, implantation sites, resorption sites and survival (live and dead fetuses)
- Fetal examinations:
- - External examinations: Yes, all per litter were examined grossly for the presence of external congenital abnormalities
- Soft tissue examinations: Yes, one-third of the fetuses of each litter underwent detailed visceral examinations employing the Wilson technique
- Skeletal examinations: Yes, the remaining two-thirds were cleared in potassium hydroxide, stained with alizarin red S dye and examined for skeletal defects. - Statistics:
- No data
- Indices:
- Sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses
- Historical control data:
- No data
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- not specified
- Description (incidence and severity):
- Results not further specified
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- No mortality occurred
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on body weight were observed in comparison to the untreated control
- Food consumption and compound intake (if feeding study):
- not specified
- Description (incidence and severity):
- Results not further specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No adverse effects observed during gross necrosy in comparison to the untreated control
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- The administration of up to 310 mg/kg bw/day of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on maternal survival.
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Description (incidence and severity):
- No abortion occured in any pregnant female rat.
- Pre- and post-implantation loss:
- not examined
- Total litter losses by resorption:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on resorptions after dosing with potassium chloride when compared with the controls.
- Early or late resorptions:
- not examined
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on dead fetuses after dosing with potassium chloride when compared with the controls.
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on the number of pregant females after dosing with potassium chloride when compared with the controls.
- Other effects:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on the number of corpora lutea after dosing with potassium chloride when compared with the controls.
- Details on maternal toxic effects:
- The administration of up to 310 mg/kg bw of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on nidation or on maternal or fetal survival.
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 310 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse effects observed at the highest dose tested
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on fetal body weight after dosing with potassium chloride when compared with the controls.
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on live fetuses after dosing with potassium chloride when compared with the controls.
- Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on sex ratio after dosing with potassium chloride when compared with the controls.
- Changes in litter size and weights:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on litter size after dosing with potassium chloride when compared with the controls.
- Changes in postnatal survival:
- not examined
- External malformations:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on external malformations after dosing with potassium chloride when compared with the controls.
- Skeletal malformations:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on skelatal malformations after dosing with potassium chloride when compared with the controls.
- Visceral malformations:
- no effects observed
- Description (incidence and severity):
- There were no notable effects on visceral malformations after dosing with potassium chloride when compared with the controls.
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- The administration of up to 310 mg/kg bw of the test material to pregnant rats for 10 consecutive days had no clearly discernible effect on fetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occuring spontaneously in the sham-treated controls.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 310 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed at the highest dose tested
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- In this study conducted similar to OECD Guideline 414, oral administration of potassium chloride given once a day to Wistar rat dams from Day 6 to 15 of gestation was well tolerated of up to 310 mg/kg bw/day. As no adverse results were observed in any examined parameter, the NOAEL for reproductive/developmental and maternal toxicity is considered to be greater than 310 mg/kg bw/day.
- Executive summary:
In a developmental toxicity study performed similar to OECD 414, potassium chloride was administered to groups of 20-23 pregnant adult female Wistar rats/dose by gavage at dose levels of 0, 3.1, 14.4, 66.8 and 310.0 mg/kg bw/day from day 6 through day 15 of gestation. The animals were sacrificed on gestation day 20.
No treatment-related effects were seen in maternal or offspring survival. Regarding maternal toxicity, no effects were seen in the total number of corpora lutea, implant sites, resorptions, soft tissue observations or live foetuses. Regarding the foetuses, no effects were noticed in sex ratio and average foetus weight. In addition, no differences were seen in either soft or skeletal examinations. As no adverse results were observed in any examined parameter, the NOAEL for reproductive/developmental and maternal toxicity is considered to be greater than 310 mg/kg bw/day.
The developmental toxicity study in the rat is classified acceptable and satisfies the guideline requirement for a developmental toxicity study (according to OECD 414) in rats.
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